epoetin alfa

What is the most important information I should know about epoetin alfa?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Epoetin alfa may also shorten remission time or survival time in some people with certain types of cancer. Talk with your doctor about the risks and benefits of using epoetin alfa.

You should not use this medicine if you have uncontrolled high blood pressure, or if you have ever had pure red cell aplasia (PRCA, a type of anemia) caused by using epoetin alfa or darbepoetin alfa or (Aranesp).

What is epoetin alfa?

Epoetin alfa is a man-made form of a protein that helps your body produce red blood cells. This protein may be reduced when you have kidney failure or use certain medications. When fewer red blood cells are produced, you can develop a condition called anemia.

Epoetin alfa is used to treat anemia caused by chemotherapy or chronic kidney disease. Epoetin alfa is also used to reduce the need for red blood cell transfusions in people having certain types of surgery.

Epoetin alfa is available to cancer patients only under a special program called ESA APPRISE. You must be registered in the program and understand the risks and benefits of using this medicine.

Epoetin alfa may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using epoetin alfa?

You should not use this medication if you are allergic to epoetin alfa or darbepoetin alfa or (Aranesp), or if:

you have untreated or uncontrolled high blood pressure;

you have had pure red cell aplasia (PRCA, a type of anemia) after using darbepoetin alfa or epoetin alfa; or

you use an epoetin alfa multi-dose vial and you are pregnant or breast-feeding.

Do not use epoetin alfa from a multi-dose vial when giving medicine to a baby. The multi-dose vial contains an ingredient that can cause serious side effects or death in very young infants or premature babies.

Epoetin alfa may shorten remission time in some people with head and neck cancer who are also being treated with radiation. Epoetin alfa may also shorten survival time in certain people with breast cancer, non-small cell lung cancer, head and neck cancer, cervical cancer, or lymphoid cancer. Talk with your doctor about your individual risk.

To make sure epoetin alfa is safe for you, tell your doctor if you have;

heart disease, high blood pressure;

kidney disease (or if you are on dialysis);

a seizure disorder; or

a history of stroke, heart attack, or blood clots.

Using epoetin alfa during pregnancy could harm the unborn baby. Tell your doctor if you are pregnant or if you become pregnant while using this medicine.

It is not known whether epoetin alfa passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not use epoetin alfa from a multi-dose vial if you are pregnant or breast-feeding.

Epoetin alfa is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How should I use epoetin alfa?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Epoetin alfa is injected under the skin, or into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose. Throw away any leftover medicine in a multi-dose vial 21 days after the first use.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your injections may be delayed based on the results of these tests.

You may need to take blood pressure medication while you are using epoetin alfa. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

If you need surgery, tell the surgeon ahead of time that you are using epoetin alfa. You may need to use a medicine to prevent blood clots.

Call your doctor if you feel weak, tired, light-headed, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to epoetin alfa.

Epoetin alfa is only part of a complete treatment program that may also include a special diet. Follow your doctor's instructions very closely.

Store in the refrigerator and protect from light. Do not freeze epoetin alfa, and throw away the medication if it has become frozen.

Do not shake the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of epoetin alfa.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using epoetin alfa?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What are the possible side effects of epoetin alfa?

Get emergency medical help if you have signs of an allergic reaction: hives, sweating; rapid pulse; wheezing, difficult breathing; severe dizziness or fainting; swelling of your face, lips, tongue, or throat.

Epoetin alfa can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use this medicine. Seek emergency medical help if you have:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect epoetin alfa?

Other drugs may interact with epoetin alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about epoetin alfa.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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